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Job Description

About the role:

As a Quality Control Analyst II, ensure that products meet the highest standards of quality and consistency throughout the production process. Quality Control Lead is also responsible for leading a team of analysts, ensuring compliance with local, global, and regulatory standards are maintained. You will support safety, customer satisfaction, employee development, and continuous improvement, consistent with plant goals. Additionally, the Lead Analyst leads a team of QC professionals, conducting root cause analysis for defects, collaborating with cross-functional teams, and driving continuous improvement efforts to optimize quality and efficiency.

The hours of this position are 6PM-6:30AM, 2-2-3; weekend and holiday work. Overtime may be required.

How you will contribute:

• Lead ongoing, daily departmental operations.
• May include the guidance of assigned personnel in achieving defined quality goals. Interview/hire, evaluate, train, and develop direct reports.
• Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques. Determine the logic, adequacy and effectiveness of systems and related requirements. Develop plans to correct identified risks including areas of non-conformance, inform management and implement approved corrective action plans.
• Write, review, analyze, and revise written Standard Operating Procedures (SOPs) and submit procedural changes to meet Corporate, Divisional, Plant, Regulatory Requirements.
• Navigate, answer alerts and review Batch Records in EBM.
• Provide necessary floor support to the manufacturing teams and help in resolving compliance concerns.
• Support external audits.
• Help with audits of multiple reports (Protocols, Qualifications, Regulatory Submissions)
• Be a Subject Matter Expert (SME) and provide training to local employees on relevant area(s).
• Identify when proper practices/ procedures are not performed. Follow SOPs and identify processes and results.
• Implement changes and corrections. Escalate accordingly. Ensure communication of issues.
• Ensure communications between personnel, groups, and between departments.
• Coordinate activities and schedules staff.

What you bring to Takeda:

• Requires bachelor's degree in science, engineering or other related technical field. 2+ years of related experience.
• Proficient in wet and instrumental methods of analyses.
• Advanced laboratory skills and basic knowledge of statistical method.
• Must demonstrate effectiveness in ability to train others.
• Knowledge of most laboratory equipment including autoclaves, incubators and analytical equipment.
• Must be proficient in multiple mathematical operations and calculations and be able to work with both the metric and US standards of measurements.
• Will read and follow detailed written instructions and have good verbal/written communication skills.
• Knowledge of basic chemical and biological safety procedures.
• Knowledge of Microsoft Word, Excel and PowerPoint.

Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• In gener